Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT02231450
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged between 40 and 65 years (inclusive) with a body mass index between 19 and 32 kg/m2 (inclusive).
* Group 1: Patients with mild hepatic impairment (Child-Pugh's Criteria A, score 5-6)
* Group 2: Patients with moderate hepatic impairment (Child-Pugh's Criteria B, score 7-9)
* Group 3: Healthy subjects with normal hepatic function
Other pre-defined inclusion and exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT02231450
Study Brief:
Protocol Section:
NCT02231450